Study of Metabolic Syndrome in Adolescent and Young Adult Survivors of Childhood Leukemia Who Have Undergone Stem Cell Transplant
Metabolic Syndrome Following Transplant for Leukemia
RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood leukemia who have undergone stem cell transplant may help doctors learn more about the disease and the long-term effects of leukemia treatment. It may also help improve the quality of life for future cancer survivors.
PURPOSE: This clinical trial is studying metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone stem cell transplant.
調査の概要
状態
詳細な説明
OBJECTIVES:
- To determine the prevalence of metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone hematopoietic stem cell transplantation (HSCT) and compare the extent to which prevalence is higher in HSCT survivors than in age- and gender-matched population norms derived from the Third National Health and Nutrition Examination Survey (NHANES III).
- To evaluate the relationship between insulin resistance and risk factors associated with metabolic syndrome (e.g., hypertension, obesity, hyperinsulinemia, and dyslipidemia) as measured by euglycemic insulin clamp, fasting serum insulin, glucose, lipids (total cholesterol, triglycerides, LDL-C, and HDL-C), blood pressure and anthropometric measurements, and DEXA scan in these patients and compare to age- and gender-matched population norms.
- To assess the extent to which prevalent obesity and insulin resistance are correlated with other factors that have been identified in the causal pathway associated with the development of metabolic syndrome and that may be altered after HSCT, including growth hormone secretion, adipokines (adiponectin and leptin), and inflammatory mediators (interleukin-6, tumor necrosis factor-α, and C-reactive protein).
- To evaluate the association of metabolic syndrome and early signs of impaired endothelial function and cardiovascular changes.
- To evaluate health behaviors related to prevention of cardiovascular disease, diabetes, and obesity, including a physical activity assessment, a dietary assessment, and a health knowledge assessment that will be used in the analyses of metabolic syndrome, growth hormone deficiency, and indicators of cardiovascular disease.
OUTLINE: Patients are stratified according to post-transplant follow-up period (2-9 years vs 10-15 years vs > 15 years).
Patients and their siblings undergo physical examination, a review of medical and family history, and blood pressure and anthropometric measurements. Patients and their siblings also undergo blood sample collection for laboratory studies (including analysis of C-reactive protein and CBC; lipid profile and triglycerides; leptin and adipokines; free thyroxine, TSH, IGF1, IGF3, and LH; and estradiol [females] or testosterone [males]); urine sample collection for microalbumin determination; and other study procedures (including euglycemic insulin clamp study; body composition and bone density [DEXA] study; bone-age x-ray [for patients < 18 years of age]; and vascular studies). Patients also undergo growth hormone stimulation testing.
Patients and their siblings complete questionnaires about their physical activity, dietary habits, and health knowledge.
PROJECTED ACCRUAL: A total of 193 childhood leukemia survivors and 193 healthy siblings will be accrued for this study.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Washington
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Seattle、Washington、アメリカ、98105
- Clinical Research Center - Seattle Children's Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Survivor of childhood leukemia, meeting all of the following criteria:
- 21 years of age and under at diagnosis
- Has undergone hematopoietic stem cell transplantation (HSCT) at Fairview University Medical Center or Fred Hutchinson Cancer Research Center ≥ 2 years ago
- Disease in remission
- Healthy sibling of a childhood leukemia survivor
PATIENT CHARACTERISTICS:
- Not pregnant
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Comparison of the prevalence of metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone hematopoietic stem cell transplantation (HSCT) with age- and gender-matched controls
時間枠:≥2 years post-HSCT
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≥2 years post-HSCT
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Comparison of insulin resistance in patients with age- and gender-matched controls
時間枠:≥2 years post-HSCT
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≥2 years post-HSCT
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Correlation between insulin sensitivity and risk factors associated with metabolic syndrome
時間枠:≥2 years post-HSCT
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≥2 years post-HSCT
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Influence of time since transplant on insulin resistance
時間枠:≥2 years post-HSCT
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≥2 years post-HSCT
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Peak growth hormone secretion in patients with insulin resistance and in those without
時間枠:≥2 years post-HSCT
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≥2 years post-HSCT
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Growth hormone deficiency in patients with metabolic syndrome and in those without
時間枠:≥2 years post-HSCT
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≥2 years post-HSCT
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Association of interleukin-6, tumor necrosis factor-α, C-reactive protein, and leptin with insulin resistance and central obesity
時間枠:≥2 years post-HSCT
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≥2 years post-HSCT
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Correlation of adiponectin with insulin resistance and central obesity
時間枠:≥2 years post-HSCT
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≥2 years post-HSCT
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Differences in markers for endothelium dysfunction and early indicators of cardiovascular disease
時間枠:≥2 years post-HSCT
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≥2 years post-HSCT
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Difference in important health behaviors related to obesity and cardiovascular disease between patients with metabolic syndrome and those without
時間枠:≥2 years post-HSCT
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≥2 years post-HSCT
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協力者と研究者
捜査官
- 主任研究者:K S Baker, MD, MS、Fred Hutchinson Cancer Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- IR 7141
- P30CA077598 (米国 NIH グラント/契約)
- UMN-2003NT063
- CDR0000642276 (レジストリ識別子:NCI)
- IR-6980 (その他の識別子:Former FHCRC IRB ID)
- FHCRC-2357.00 (その他の識別子:Former FHCRC ID)
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